Clinical Trial Details

Overview

Research Study Summary

Effects of Enteral Glutamine Supplementation on Mortality and Infectious Morbidity in Severely Burned Patients: a Multi-center Pilot Trial

Purpose
Enteral glutamine has been found to decrease mortality in critically ill patients and blood infection in trauma patients.
In our pilot study (Critical Care Medicine, 2003, 31:2444) we found the same protective effect of glutamine against blood infection in severely burned adult patients. In addition, a significant decrease in mortality was observed with glutamine. These results should be tested with a multi-center trial because our study was small and did not have mortality as an end point. Since such a large multi center study has never been conducted in burn patients, a pilot study that will test its feasibility seems warranted.
To Learn more

CW ID: 222887
Date Last Changed: February 2, 2017

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Queen's University
Facility Type
N/A

Eligibility

Inclusion Criteria:
  1. Deep 2nd and/or 3rd degree burns requiring grafting
  2. a.) Patients 18 - 59 years of age without inhalation injury TBSA* = 20% b.) Patients 18 - 59 years of age with inhalation injury TBSA* = 15% c.) Patients = 60 years of age (with or without inhalation injury) TBSA* = 10%
*TBSA - Total Burn Surface Area

Exclusion Criteria:

  1. 72 hrs from admission to ICU to time of consent.
  2. Patients younger than 18 years of age
  3. In patients without known renal disease, renal dysfunction defined as a serum creatinine >171 µmol/L or a urine output of less than 500 ml/last 24 hours (or 80 ml/last 4 hours if a 24 hour period of observation is not available). In patients with acute on chronic renal failure (pre-dialysis), an absolute increase of >80 µmol/L from baseline or pre-admission creatinine or a urine output of <500 ml/last 24 hours (or 80 ml/last 4 hours) will be required. Patients with chronic renal failure on dialysis will be excluded.
  4. Liver cirrhosis - Child's class C liver disease
  5. Pregnancy
  6. Absolute contra-indication for EN: intestinal occlusion or perforation, abdominal injury
  7. Patients with injuries from high voltage electrical shock
  8. Patients who are moribund
  9. Patients with extreme body sizes: BMI < 18 or > 50
  10. Enrolment in another industry sponsored ICU intervention study
  11. Received glutamine supplement for > 24 hrs prior to randomization
  12. Known allergy to maltodextrin, corn starch, corn, corn products or glutamine

Contact

Rachel Karlnoski
University of South Florida - Tampa General Hospital
1 Tampa General Circle
Tampa, FL 33606
Phone: (813) 844-4133

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